Nobilis Influenza H5N6
adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5
Table of contents
Overview
The marketing authorisation for Nobilis Influenza H5N6 has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Nobilis Influenza H5N6
|
| Agency product number |
EMEA/V/C/000125
|
| Active substance |
inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84)
|
| International non-proprietary name (INN) or common name |
adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5
|
| Species |
Chicken
|
| Anatomical therapeutic chemical veterinary (ATCvet) codes |
QI01AA23
|
Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
Exceptional circumstances |
This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Intervet International BV
|
| Revision |
1
|
| Date of issue of marketing authorisation valid throughout the European Union |
31/01/2008
|
| Contact address | |
Product information
05/07/2010 Nobilis Influenza H5N6 - EMEA/V/C/000125 - S/0001
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Immunologicals for aves
Therapeutic indication
For active immunisation of chickens against avian influenza type A, subtype H5.
Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two weeks after a single dose vaccination.
Serum antibodies have been shown to persist in chickens for at least 7 months and studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.